ImPact Biotech Reports 70% Complete Response Rate in Phase 3 ENLIGHTED Trial of Padeliporfin VTP for Low-Grade Upper Tract Urothelial Cancer
核心洞察
ImPact Biotech (搜索) presented updated interim results from the Phase 3 ENLIGHTED study showing Padeliporfin VTP achieved a 70% complete response rate in 50 evaluable patients with low-grade upper tract urothelial cancer.
All patients who completed the Maintenance Treatment Phase sustained complete responses for at least 12 months, demonstrating promising durability of the treatment response.
The vascular targeted photodynamic therapy maintained a well-tolerated safety profile with mostly mild to moderate adverse events that resolved within days.
ImPact Biotech (搜索) has reported encouraging updated interim results from its Phase 3 ENLIGHTED study, demonstrating that Padeliporfin vascular targeted photodynamic (VTP) therapy achieved a 70% complete response rate in patients with low-grade upper tract urothelial cancer (UTUC). The data, presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO 2025) in Phoenix, Arizona, represents a comprehensive analysis of 50 evaluable patients who completed the Induction Treatment Phase.
Clinical Efficacy Results
The updated analysis, based on a data cutoff of July 28, 2025, showed that 68 patients had begun treatment, with 50 completing the Induction Treatment Phase and being evaluable for efficacy. Of these 50 patients, 35 (70%) achieved a complete response at the end of the induction phase, while an additional 9 patients (18%) achieved a partial response, resulting in an overall response rate of 88%.
"We are pleased to share updated data from the Phase 3 ENLIGHTED study, which further strengthen Padeliporfin VTP's profile as a next-generation treatment option for LG UTUC with potential to improve long-term patient outcomes," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech (搜索).
Durability and Long-term Outcomes
A particularly notable finding from the updated analysis was the durability profile of the treatment. All patients (100%) who completed the Maintenance Treatment Phase sustained complete responses in the treated area for at least 12 months as of the data cutoff date. This represents the first look at the program's durability profile, with additional patients progressing through the maintenance phase who have yet to complete the 12-month evaluation period.
Safety and Tolerability Profile
Padeliporfin VTP continued to demonstrate a well-tolerated safety profile consistent with previous data from the Phase 1 study and earlier Phase 3 results. The majority of treatment-emergent adverse events were mild or moderate, primarily related to the ureteroscopic procedure, and resolved within a few days. Only one Grade 3 serious adverse event related to VTP treatment was reported, which resolved within two days. No treatment-emergent adverse events of special interest were reported, and no adverse events led to discontinuation of study treatment.
Study Design and Treatment Approach
The Phase 3 ENLIGHTED study is a single-arm, non-randomized, open-label pivotal trial conducted across 29 clinical sites globally, targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two phases: an Induction Treatment Phase and a Maintenance Treatment Phase.
During treatment, Padeliporfin, a photosensitizing drug, is administered intravenously, followed by VTP therapy performed via outpatient endoscopy. The procedure applies laser fiber illumination for 10 minutes in proximity to the tumor, leading to local activation of Padeliporfin in the tumor microenvironment. The Induction Treatment Phase consists of one to three treatments with VTP therapy at four-week intervals or until a complete response is achieved. The Maintenance Treatment Phase follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months.
Clinical Development Timeline
ImPact Biotech (搜索) continues to recruit for the ENLIGHTED study and expects to complete enrollment in the first quarter of 2026. The company anticipates presenting topline ENLIGHTED data in the first half of 2026. Dr. Morag emphasized that "Padeliporfin VTP is well-positioned to address the current unmet medical need in LG UTUC as we look to complete enrollment by Q1 2026 and report topline data in the first half of 2026."
Broader Development Program
Beyond the ENLIGHTED study in low-grade UTUC, ImPact Biotech (搜索)'s VTP platform is being evaluated in earlier-stage studies for high-grade UTUC, pancreatic ductal adenocarcinoma, and non-small cell lung cancer. The company maintains collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center, with operations spanning the EU, Israel, and the United States.
The presentation at SUO 2025 was delivered by Vitaly Margulis, M.D., Professor of Urologic Oncology at the University of Texas Southwestern Medical Center, as part of the SUO Top Abstract Tour session. The company had previously presented an encore presentation of earlier data from the Phase 3 ENLIGHTED trial at the 17th European Multidisciplinary Congress on Urological Cancers in November 2025.